5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor'
- Conditions
- Neuroendocrine Tumors
- Registration Number
- NCT02507908
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
The objective of this observational laboratory study is to measure the correlation between 5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and analysed.
- Detailed Description
In midgut NETs serotonin production is most prominent. Patients with NETs producing excessive serotonin can develop carcinoid syndrome. Serotonin is a product of the 'tryptophan pathway'. Serotonin is metabolized in 5-hydroxyindolacetic acid (5-HIAA) and then excreted with urine. 5-HIAA in 24-hour urine collection is one of the parameters used for follow up in patients with a serotonin-producing neuroendocrine tumor. This measurement has some disadvantages; it could be stressful, the collection is not always precisely, furthermore the collection could be problematic, for example in patients with diarrhea.
Since October 2013 it is possible, because of a better measurement sensitivity, to measure reliably 5-HIAA in platelet rich plasma (PRP) by isotope-dilution massa-spectrometer (LCMS-MS). Recent publications show that 5-HIAA measured in PRP could have an additive value in diagnosis and follow up of patients with serotonin-producing NET.
Objective:
The primary objective is to measure the correlation between 5-HIAA in PRP and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor.
Secondary objective is to determine if increase or decrease of 5-HIAA in plasma is associated with disease progression.
Study design:
This is an observational laboratory study. Plasma and urine of included patients and collected in standard health care, are selected and the 5-HIAA's are measured with LCMS-MS. Also age, sex, diagnosis and clinical course of the patients will be collected from the medical record.
Study population:
In this study the investigators will use blood and urine of 60 patients with serotonin-producing neuro-endocrine tumors.
Main study parameters/endpoints:
The main endpoint of this study is the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection. Secondary endpoint is the correlation between 5-HIAA in PRP and course of the disease, determined by CT-scan (if applicable).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Serotonin in platelets > 5.4 nmol / 10^9 and 5-HIAA in 24-hours urine >3.8 mmol/mol creatinine
- Adult NET patients (aged ≥ 18 years of age)
- Blood and urine collection of the patient are collected within four days Patients are allowed to be included more than once.
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection 4 days
- Secondary Outcome Measures
Name Time Method the course of the disease according to the course of 5-HIAA in plasma 1 year the course of the disease according to the course of 5-HIAA in plasma
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands